- Diabetes, obesity and metabolism
- Study Design and Protocol for a Randomized Controlled Trial to Assess Long-Term Efficacy and Safety of a Triple Combination of Ezetimibe, Fenofibrate, and Moderate-Intensity Statin in Patients with Type 2 Diabetes and Modifiable Cardiovascular Risk Factors (ENSEMBLE)
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Nam Hoon Kim, Juneyoung Lee, Suk Chon, Jae Myung Yu, In-Kyung Jeong, Soo Lim, Won Jun Kim, Keeho Song, Ho Chan Cho, Hea Min Yu, Kyoung-Ah Kim, Sang Soo Kim, Soon Hee Lee, Chong Hwa Kim, Soo Heon Kwak, Yong‐ho Lee, Choon Hee Chung, Sihoon Lee, Heung Yong Jin, Jae Hyuk Lee, Gwanpyo Koh, Sang-Yong Kim, Jaetaek Kim, Ju Hee Lee, Tae Nyun Kim, Hyun Jeong Jeon, Ji Hyun Lee, Jae-Han Jeon, Hye Jin Yoo, Hee Kyung Kim, Hyeong-Kyu Park, Il Seong Nam-Goong, Seongbin Hong, Chul Woo Ahn, Ji Hee Yu, Jong Heon Park, Keun-Gyu Park, Chan Ho Park, Kyong Hye Joung, Ohk-Hyun Ryu, Keun Yong Park, Eun-Gyoung Hong, Bong-Soo Cha, Kyu Chang Won, Yoon-Sok Chung, Sin Gon Kim
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Endocrinol Metab. 2024;39(5):722-731. Published online August 22, 2024
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DOI: https://doi.org/10.3803/EnM.2024.1995
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- Background
Atherogenic dyslipidemia, which is frequently associated with type 2 diabetes (T2D) and insulin resistance, contributes to the development of vascular complications. Statin therapy is the primary approach to dyslipidemia management in T2D, however, the role of non-statin therapy remains unclear. Ezetimibe reduces cholesterol burden by inhibiting intestinal cholesterol absorption. Fibrates lower triglyceride levels and increase high-density lipoprotein cholesterol (HDL-C) levels via peroxisome proliferator- activated receptor alpha agonism. Therefore, when combined, these drugs effectively lower non-HDL-C levels. Despite this, few clinical trials have specifically targeted non-HDL-C, and the efficacy of triple combination therapies, including statins, ezetimibe, and fibrates, has yet to be determined.
Methods This is a multicenter, prospective, randomized, open-label, active-comparator controlled trial involving 3,958 eligible participants with T2D, cardiovascular risk factors, and elevated non-HDL-C (≥100 mg/dL). Participants, already on moderate-intensity statins, will be randomly assigned to either Ezefeno (ezetimibe/fenofibrate) addition or statin dose-escalation. The primary end point is the development of a composite of major adverse cardiovascular and diabetic microvascular events over 48 months.
Conclusion This trial aims to assess whether combining statins, ezetimibe, and fenofibrate is as effective as, or possibly superior to, statin monotherapy intensification in lowering cardiovascular and microvascular disease risk for patients with T2D. This could propose a novel therapeutic approach for managing dyslipidemia in T2D.
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Citations
Citations to this article as recorded by 
- Current and Emerging Treatment Options for Hypertriglyceridemia: State-of-the-Art Review
Jakub Michal Zimodro, Manfredi Rizzo, Ioanna Gouni-Berthold Pharmaceuticals.2025; 18(2): 147. CrossRef
- Clinical Study
- Association between Bsm1 Polymorphism in Vitamin D Receptor Gene and Diabetic Retinopathy of Type 2 Diabetes in Korean Population
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Yong Joo Hong, Eun Seok Kang, Myoung Jin Ji, Hyung Jin Choi, Taekeun Oh, Sung-Soo Koong, Hyun Jeong Jeon
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Endocrinol Metab. 2015;30(4):469-474. Published online December 31, 2015
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DOI: https://doi.org/10.3803/EnM.2015.30.4.469
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5,438
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- Background
Type 2 diabetes is one of the most common diseases with devastating complications. However, genetic susceptibility of diabetic complications has not been clarified. The vitamin D endocrine system is related with calcification and lipolysis, insulin secretion, and may be associated with many complicated disease including diabetes and cardiovascular disease. Recent studies reported that single nucleotide polymorphisms of vitamin D receptor (VDR) gene were associated with diabetic complications. MethodsIn present study, we evaluated the association of BsmI polymorphism of VDR with diabetic complications in Korean diabetes patients. Total of 537 type 2 diabetic subjects from the Endocrinology Clinic of Chungbuk National University Hospital were investigated. Polymerase chain reaction-restriction fragment length polymorphism was used to test the genotype and allele frequency of BsmI (rs1544410; BB, Bb, bb) polymorphisms. ResultsMean age was 62.44±10.64 years and mean disease duration was 13.65±7.39 years. Patients with B allele (BB or Bb) was significantly associated with lower risk of diabetic retinopathy (severe non-proliferative diabetic retinopathy or proliferative retinopathy; 7.4%, 5/68) compared with patients without B allele (bb; 17.3%, 81/469; P=0.035). This association was also significant after adjusting for hemoglobin A1c level, body mass index, age, sex, and diabetes mellitus duration, concurrent dyslipidemia and hypertension (odds ratio, 2.99; 95% confidence interval, 1.08 to 8.29; P=0.035) in logistic regression analysis. ConclusionOur findings suggest that B allele of Bsm1 polymorphism in VDR gene is associated with lower risk of diabetic retinopathy in type 2 diabetic patients. Bsm1 genotype could be used as a susceptibility marker to predict the risk of diabetes complication.
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Citations
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- Meta-analysis of genes and genetic variants implicated in Type II diabetes mellitus, diabetic retinopathy, and diabetic nephropathy
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Serkan YILDIZ, Serbülent YİĞİT, Ayşe Feyda NURSAL, Nevin KARAKUŞ, Mehmet Kemal TÜMER ADO Klinik Bilimler Dergisi.2024; 13(1): 100. CrossRef - Emerging role of vitamin D deficiency as a risk factor for retinal venous occlusions and need for public health measures for its prevention
Pramod Kumar Sahu, Priyanka Gautam, Gopal Krushna Das, Priyanka Gogoi, Nitika Beri, Rahul Bhatia Journal of Family Medicine and Primary Care.2024; 13(8): 3298. CrossRef - Effect of VDR and TLR2 gene variants on the clinical course of patients with COVID-19 disease
Nilufer Kuruca, Aynur Atilla, Muhammed Taha Kaya, Sedat Gokmen, Ayse Feyda Nursal, Ozgur Kilic, Tuba Kuruoglu, Fatih Temocin, Tolga Guvenc, Serbulent Yigit, Dilek Guvenc Journal of Investigative Medicine.2024; 72(8): 876. CrossRef - Vitamin D Deficiency as a Risk Factor for Diabetic Retinopathy: A Systematic Review and Meta-Analysis
Claudia Elena Petrea, Laura Andreea Ghenciu, Roxana Iacob, Emil Robert Stoicescu, Dorel Săndesc Biomedicines.2024; 13(1): 68. CrossRef - Association analysis between the VDR gene variants and type 2 diabetes
Shabnam Salehizadeh, Sara Ramezani, Mojgan Asadi, Mahdi Afshari, Seyed Hamid Jamaldini, Farhad Adhami Moghadam, Mandana Hasanzad Journal of Diabetes & Metabolic Disorders.2023; 23(1): 633. CrossRef - Metabolic impact of the VDR rs1544410 in diabetic retinopathy
Caroline Severo de Assis, Tainá Gomes Diniz, João Otávio Scarano Alcântara, Vanessa Polyana Alves de Sousa Brito, Rayner Anderson Ferreira do Nascimento, Mayara Karla dos Santos Nunes, Alexandre Sérgio Silva, Isabella Wanderley de Queiroga Evangelista, Ma PLOS ONE.2022; 17(2): e0263346. CrossRef - Vitamin D, the Vitamin D Receptor, Calcitriol Analogues and Their Link with Ocular Diseases
Miłosz Caban, Urszula Lewandowska Nutrients.2022; 14(11): 2353. CrossRef - Vitamin D-Related Single Nucleotide Polymorphisms as Risk Biomarker of Cardiovascular Disease
Paula González Rojo, Cristina Pérez Ramírez, José María Gálvez Navas, Laura Elena Pineda Lancheros, Susana Rojo Tolosa, María del Carmen Ramírez Tortosa, Alberto Jiménez Morales International Journal of Molecular Sciences.2022; 23(15): 8686. CrossRef - Effects of Vitamin D Receptor Genotype on Lipid Profiles and Retinopathy Risk in Type 2 Diabetes Patients: A Pilot Study
Hussam Alhawari, Yazun Jarrar, Dina Abulebdah, Sara J. Abaalkhail, Marah Alkhalili, Sura Alkhalili, Hussein Alhawari, Munther Momani, Mohammed N. Obeidat, Rand K. Fram, Mohammad A. Salahat, Su-Jun Lee Journal of Personalized Medicine.2022; 12(9): 1488. CrossRef - Relation of vitamin D and BsmI variant with temporomandibular diseases in the Turkish population
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Zohreh Salari, Nasrollah Saleh-Gohari, Monire Rezapour, Ahamad Khosravi, Hadi Tavakkoli, Ehsan Salarkia, Fatemeh Karami-Robati Meta Gene.2021; 27: 100833. CrossRef - Association of Bone Metabolism Indices and Bone Mineral Density with Diabetic Retinopathy in Elderly Patients with Type 2 Diabetes Mellitus: A Cross-Sectional Inpatient Study in China
Xin Zhao, Lili Huo, Xiaofeng Yu, Xiaomei Zhang, Fabio Vescini Journal of Diabetes Research.2021; 2021: 1. CrossRef - The Associations Between Vitamin D Receptor BsmI and ApaI Polymorphisms and Obesity in Korean Patients with Type 2 Diabetes Mellitus
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Amir Kiani, Ehsan Mohamadi-Nori, Asad Vaisi-Raygani, Maryam Tanhapour, Said Elahi-Rad, Fariborz Bahrehmand, Zohreh Rahimi, Tayebeh Pourmotabbed Molecular Biology Reports.2019; 46(5): 5225. CrossRef - Is Hypovitaminosis D Related to Incidence of Type 2 Diabetes and High Fasting Glucose Level in Healthy Subjects: A Systematic Review and Meta-Analysis of Observational Studies
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- A Case of Lingual Thyroid Treated by 131I Ablation.
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Myeong Ho Yeon, Yong Hyeok Choi, Young Rak Choi, Woo Ri Park, Hyung Jin Choi, Tae Keun Oh, Hyun Jeong Jeon
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Endocrinol Metab. 2012;27(4):303-307. Published online December 20, 2012
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DOI: https://doi.org/10.3803/EnM.2012.27.4.303
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- A lingual thyroid is a rare developmental anomaly caused by the failure of the descent of the thyroid gland anlage early in the course of embryogenesis. The incidence of lingual thyroid has been reported to be 1/100,000. Lingual thyroid is often asymptomatic but may cause dysphagia, dysphonia, upper airway obstruction and hemorrhage. In this report, we described the case of a 50-year-old women experiencing lingual thyroid who had subclinical hypothyroidism. She underwent successful 131I ablation and has done well on thyroid hormone replacement therapy.
- A Case of Cushing's Disease in Pregnancy.
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Jeong Tae Kim, Mun Hyuk Sung, Woo Ri Park, Jeong Ho Han, Hye Suk Han, Young Kwang Sim, Tae Gun Oh, Hyun Jeong Jeon
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Endocrinol Metab. 2011;26(4):348-354. Published online December 1, 2011
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DOI: https://doi.org/10.3803/EnM.2011.26.4.348
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- Developing Cushing's syndrome during pregnancy is rare because menstruation is irregular and hypercortisolism causes infertility. Developing Cushing's disease during pregnancy is very rare because there is even less ovulation than those with the adrenal adenoma. The clinical manifestations of Cushing's syndrome may easily be missed during pregnancy as the features of weight gain, hypertension, and hyperglycemia overlap with those that occur during a pregnancy. Diagnosing Cushing's syndrome during a pregnancy is complex because the biochemical features are obscured by the natural changes in the hypothalamic-pituitary-adrenal axis that occur during pregnancy. Having Cushing's syndrome during a pregnancy results in increased fetal and maternal complications, so early diagnosis and treatment are critical. We report the clinical and endocrine findings of a pregnant women with Cushing's disease who underwent transsphenoidal surgery after delivery.
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